Safeguarding public health

MEDICAL DEVICE ALERT

Issued: 03 March 2008 at 10:30 Ref: MDA/2008/010

Immediate action

9 Action
Update
Information request

Device: ►Page 2
Ambulift hoist. All models manufactured by Arjo or Mechanaids.
Problem: ►Page 2
Risk of the occupant slipping from the seat during use.
Action by:
All those involved in the use of patient hoists, in particular nurses, care staff and moving and
handling co-ordinators.
Action:
• Trace all mobile and static Ambulift hoists.
• Contact Arjo Huntleigh to arrange supply of a safety seat belt and revised instructions for use.
• Arrange for the new seat belt to be fitted to all Ambulifts in use or in storage.
• Ensure all users are aware of the need to use the safety belt in accordance with the latest
instructions for use.
Distributed to:
NHS trusts in England – Chief Executives*
OFSTED – Directors of Children’s Services
Commission for Social Care Inspection (CSCI) – Headquarters ►Page 2
Healthcare Commission (CHAI) – Headquarters
Primary care trusts in England – Chief Executives*
Social services in England – Directors*
* via CE Bulletin
Contacts:
Details of manufacturer contacts and MHRA contacts for technical and clinical aspects. ►Page 3
Change of address or removal from address list for CSCI and Healthcare Commission.

Action deadlines for the Safety Alert Broadcast System (SABS)

Deadline (action underway) : 03 April 2008 Deadline (action complete): 03 June 2008

This notice is also on our website: http://www.mhra.gov.uk

Medicines and Healthcare products Regulatory Agency Page 1 of 3
Issued: 03 March 2008 at 10:30 Ref: MDA/2008/010

Device:
All models of Ambulift mobile and fixed (static) hoists previously marketed as Mechanaids Ambulift, Arjo
Mechanaids Ambulift or Arjo Ambulift. Arjo Huntleigh is the present manufacturer.

Problem:
The MHRA investigated a fatality involving an occupant being transferred into a bath using an Ambulift hoist.
The tubular armrests fitted to the hoist which curve around the front of the occupant are hinged at the rear of
the seat and do not have a positive lock to keep them in place during the hoist operation. The armrests
pushed up allowing the occupant to slip down and out of the seat and sustain fatal injuries. The hoist
operator was unable to stop the occupant sliding out. This incident could easily reoccur unless a safety
device is fitted to all hoists.

The manufacturer has agreed to provide a new safety seat belt and updated instructions for use for all
Ambulift hoists. The belt is anchored to the hoist behind the seat. The belt needs to be adjusted to suit the
occupant before each hoist operation, in accordance with the new instructions for use. The new belt should
be fitted to all Ambulift hoists to remove the possibility of the reoccurrence of a similar incident.

Distribution:
Please bring this notice to the attention of all who need to know or be aware of it. This may include
distribution by:
Trusts to: OFSTED to:
SABS liaison officers for onward distribution to • Director of children’s services for onward distribution
all relevant staff including: • Schools with facilities for the disabled
• All wards
• Equipment stores Healthcare Commission (CHAI) to:
• Estates and facilities managers Headquarters for onward distribution to:
• Health and safety managers • Hospices
• Maintenance staff and contractors • Hospitals in the independent sector
• Moving and handling co-ordinators
• Nursing executive directors Commission for Social Care Inspection (CSCI) to:
• Nursing staff Headquarters for onward distribution to:
• Occupational therapists • Care homes
• Physiotherapists
• Purchasing managers
• Risk managers
• Safety officers

Primary care trusts to: Social services to:

SABS liaison officers for onward distribution to Liaison officers for onward distribution to
all relevant staff including all relevant staff including:
• Community equipment stores • Care at home staff
• Community hospitals • Care homes
• District nurses • Care management team managers
• Estates and facilities managers • Day centres
• Health and safety managers • Equipment stores
• Maintenance staff and contractors • Equipment supplies managers
• Moving and handling co-ordinators • In-house residential care homes
• Nursing staff • Loaned equipment store managers
• Occupational therapists • Maintenance staff and contractors
• Physiotherapists • Manual handling trainers
• Purchasing managers • Nursing staff
• Risk managers • Occupational therapists

Medicines and Healthcare products Regulatory Agency Page 2 of 3

Issued: 03 March 2008 at 10:30 Ref: MDA/2008/010

Contacts:
Enquiries to the manufacturer should be addressed to:
Customer Support
Arjo Huntleigh
St Catherine Street
Gloucester
GL1 2SL
Tel: 08702 430 430
Fax: 01452 428 344
E-mail: uksales@arjo.co.uk

Enquiries to the MHRA should quote reference number MDA/2008/010 or 2007/002/028/291/001 and be
addressed to:
Technical aspects: Clinical aspects:
John Ward or Sharon Knight Dr Susanne Ludgate
Medicines & Healthcare products Regulatory Agency Medicines & Healthcare products Regulatory Agency
Market Towers Market Towers
1 Nine Elms Lane 1 Nine Elms Lane
London SW8 5NQ London SW8 5NQ
Tel: 020 7084 3232 / 3202 Tel: 020 7084 3123
Fax: 020 7084 3209 Fax: 020 7084 3111
E-mail: john.ward@mhra.gsi.gov.uk E-mail: susanne.ludgate@mhra.gsi.gov.uk
sharon.knight@mhra.gsi.gov.uk
Change of address or removal from address list for CSCI and Healthcare Commission:
CSCI Customer Service Unit Healthcare Commission
St Nicholas Building Finsbury Tower
St Nicholas Street 103-105 Bunhill Row
Newcastle-upon-Tyne London
NE1 1NB EC1Y 8TG
Tel: 0845 015 0120 Tel: 020 7448 0842
E-mail: enquiries@csci.gsi.gov.uk E-mail: contacts@healthcarecommission.org.uk

How to report adverse incidents

Incidents relating to medical devices must be reported to the Medicines and Healthcare products
Regulatory Agency (MHRA) as soon as possible.
Further information about reporting incidents; on-line incident reporting facilities; and
downloadable report forms are available from MHRA's website (http://www.mhra.gov.uk).

Alternatively, further information and printed incident report forms are available from:
MHRA Adverse Incident Centre
Medicines and Healthcare products Regulatory Agency
Market Towers, 1 Nine Elms Lane, London SW8 5NQ
Telephone 020 7084 3080 or Fax 020 7084 3109
or e-mail: aic@mhra.gsi.gov.uk
(An answerphone service operates outside normal office hours)

Medical Device Alerts are available in full text on the MHRA website: http://www.mhra.gov.uk
Further information about SABS can be found at www.info.doh.gov.uk/sar2/cmopatie.nsf

MHRA is an executive agency of the Department of Health

© Crown Copyright 2008
Addressees may take copies for distribution within their own organisations

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